Webinar: (09-2023) Questions in Everyday IRB Deliberations: An Interactive, Case-Based Approach

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Description

IRB review of human subjects research consistently presents a wide variety of ethical and regulatory challenges in even the simplest of research protocols. In this session, we will explore several of a wide variety of biomedical and social and behavioral science studies, and parse out the often thorny ethical and regulatory issues that are part and parcel of an IRB’s everyday reviews.

Potential topics include ethical justification for randomized clinical trials; use of placebo; fCOI; inclusion (and exclusion) of vulnerable subjects; phase 1 trials and risk-benefit analysis; compensation (and coercion) of subjects; optimizing informed consent; secondary research findings; data and safety monitoring; and assessment and minimization of risk.

This case study-based Zoom meeting offers attendees the opportunity to interact with the speakers and other participants on screen. Through a combination of active audience participation and very brief didactic episodes, the speakers will highlight the challenges, how those challenges fit within the regulatory criteria for approval, and best practices for review. Attendees will leave with a framework for IRB members and administrators to use in effectively reviewing protocols involving these thorny components.

What will I learn to do?

Describe how to use the ethical and regulatory framework in the Common Rule to address challenging components of everyday IRB deliberations

Who should attend?
This program is geared toward HRPP/IRB personnel and those working in research programs more broadly including HRPP/IRB directors, members, chairs; researchers and research staff; and more.

Discounts available for groups of various sizes from a single institution!

Buy 4 get 1 free
Buy 12 get 6 free

To receive complimentary registrations, first register the paid registrants (e.g. if you’re using the buy 4 get 1 free discount, register the 4 paid individuals first) and then email onlinelearning@primr.org with a list of those paid individuals, as well as the name(s) and emails of those to receive complimentary registration.

Group discount requests must be received at least 24 hours before the event broadcast begins. Refunds or retroactive discounts are not available.

Access Interval
Access to live content will be available for 90 days after the recording is made available. After 90 days, access to the content will be removed, but users will retain access to any certificates of attendance earned. To earn a certificate, one must complete all required sections and complete the certificate section within the 90-day access period. After access has expired, users can purchase an additional 90 days of access.

If you prefer, you can find a paper registration form here. Please send the completed form to registration@primr.org.

*Please note that you cannot purchase this webinar on behalf of others. If you would like to register a colleague or a group, please fill out the paper form or contact onlinelearning@primr.org for an invoice

Contributors

Bruce Gordon, MD

Bruce Gordon is Assistant Vice-Chancellor for Regulatory Affairs, and Professor of Pediatrics in the Division of Pediatric Hematology/Oncology at the University of Nebraska Medical Center (UNMC). Dr. Gordon has been a member of the UNMC institutional review board since 1992, served as chair since 1996, and as executive chair since 2011.

He has served on a variety of national committees and task forces, including the Secretary's Advisory Committee on Human Research Protections Subpart A Subcommittee, the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the NIH Regulatory Burden Advisory Group Human Research Subcommittee, the AAMC Informed Consent Working Group, and the National Institute of Environmental Health Sciences (NIEHS) Best Practices Working Group for IRB Review of Disaster and Emergency Related Public Health Research. He was the first chair of the National Cancer Institute Pediatric Central IRB.

Dr. Gordon served on the Board of Director’s for PRIMR from 2015 to 2021. He has been a faculty member at every ARENA/PRIMR national meeting since 2002, and was the co-chair for the 2009 AER Conference. He is an active participant in PRIMR’s "At Your Doorstep" educational programs, including IRB 101, 200 and 250 programs.

He was co-developer of the Investigator Responsibility pre-conference workshop at the 2008 through 2011 annual meetings. He co-developed “Collaborating for Compliance” workshop, which has been presented as a stand-alone program since 2013. He co-developed an “IRB Chairs Boot Camp” program, which was presented at the 2014 and 2016 PRIMR AER meetings. He co-developed a “Vulnerable Subjects” program which was presented at the 2016 PRIMR AER meeting, and is currently part of the “At Your Doorstep” curriculum.

Dr. Gordon serves on the AAHRPP Council on Accreditation, and has been a faculty member at numerous AAHRPP conferences and a frequent AAHRPP site visitor. He is a founding member of the Collaborative Institutional Training Initiative (CITI) and served on the Executive Advisory Committee for the program. He is the author of two modules for the Human Subjects Research course. He co-developed a course related to research involving vulnerable subjects, and is the author of three modules for that course

Dr. Gordon is the author of numerous original papers, chapters, review articles, and abstracts regarding human subjects protections and research ethics, and is the co-editor of the third edition of “IRB: Management and Function.”
Sue Logsdon

Ms. Logsdon is a Senior IRB Analyst in the Office of Regulatory Affairs at the University of Nebraska Medical Center (UNMC) with more than 18 years' experience in the field. She has particular expertise in research involving human biologic materials (including FDA regulations concerning IVDDs and LDTs), and in exercise science and biomechanics. She is the author of numerous papers and has presented locally [and nationally] on a variety of topics related to the ethics involving human subjects research. Ms. Logsdon is co-author of "Research Involving Human Biospecimens” in the 3rd edition of “IRB: Management and Function” . She received her Master’s degree in exercise science from Virginia Tech. Before beginning her career at UNMC, she worked at Creighton University conducting research focused on the prevention of osteoporosis and falls in the elderly.

Thank you

Description

Contributors

Bruce Gordon, MD

Sue Logsdon